An ISO home for makers of medical devices

September 12, 2012 9:45 pm Published by

StethoscopeISO standards can relate to nearly any kind of business, large or small, across different industries.

Some industries, like aviation, space and defense (ASD), have standards addressing their unique needs.

Another example is the medical device industry. If your company manufactures medical devices, there’s a certification of your own – ISO 13485:2003.

This standard is applicable for every type of medical device – from a low-risk to a high-risk medical device. ISO 13485 is an international standard that focuses on companies manufacturing medical devices. Like ISO 9001:2008, ISO 13485 is a management system that uses a process approach to manage a medical device organization.

As with any solid business system, this standard focuses on a company defining its quality policy and then setting measurable objectives that substantiate the implementation of the quality policy and system. These results should be the drivers for your company – what is important to make the company succeed.

However, one important distinction about ISO 13485 is that you can obtain certification but still be in noncompliance with a country’s regulatory institution. So keep in mind, a company may be certified with ISO 13485 and be in compliance with European regulations, but be out of compliance with the USA-FDA requirements. Part of the ISO 13485 criteria as stated in clause 4.2.1, “any other documentation specified by national or regional regulations.”

Fortunately, D’Ardenne Associates has an ISO 13485 expert to steer you through this. We recently welcomed Beth Steuart to our team. She has 35 years of extensive experience in manufacturing, including leadership in development, implementation, maintenance and auditing of business management systems, with a great deal of expertise in medical devices.

Ready to take the step to ISO 13485? We’re here to help.


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This post was written by Roy D'Ardenne